NCT01671657Unknown不适用
US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of implantation
研究概览
简要总结
The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.
详细描述
The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- •IVF cycle attempts ≤
- •Egg age ≤ 40 years.
- •Planned Day 3 embryo transfer.
- •At least 4 normally fertilized eggs (2PN).
- •All 2PN embryos must be imaged by Eeva.
- •Ejaculated sperm or sperm from the epididymis (fresh or frozen).
- •Willing to comply with study protocol and procedures.
- •Willing to provide written informed consent.
排除标准
- •Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- •Planned "freeze all" cycle (oocytes or embryos).
- •Sperm retrieved from testicular tissue.
- •Abnormal uterine cavity as evaluated by standard methods.
- •Gestational carrier.
- •Endometriosis
- •Hydrosalpinx.
- •History of cancer.
- •Concurrent participation in another clinical study.
结局指标
主要结局
Rate of implantation
时间窗: 5-6 gestational age
To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group).
次要结局
- To evaluate clinical pregnancy rates from the Eeva Test group to the Control group(5-6 weeks gestational age)
- Spontaneous miscarriage rate(Gestational age week 8-12)
- Ongoing pregnancy rate(Gestational age week 8-12)
- Multiple pregnancy rate(Gestational age weeks 5-6 and 8-12)
研究者
研究点 (1)
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